- Nassif Wholesale LLC., of Palm Springs, FL did not have a FSVP for Sesame seeds, tahini and Semolina imported from (b)(4).
- Fatima Brothers Inc. located at 5601 56th Dr. Maspeth, NY did not have a FSVP in place for Boiled Rice and Cake rusk.
- Prime Line Distributors Inc., located at 2800 SW 42nd St. Ft. Lauderdale FL did not have a FSVP for Hazelnut Paste, Gran Padano Cheese and Parmigiano Reggiano Cheese
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nassif-wholesale-llc-604640-03192020
WARNING LETTER
Nassif Wholesale LLC
MARCS-CMS 604640 — March 19, 2020
Recipient:
Paul Nassif
Owner
Nassif Wholesale LLC
3330 2nd Avenue N Suite 8
Palm Springs, FL 33461-3651
United States
Issuing Office:
Division of Southeast Imports
United States
WARNING LETTER
March 19, 2020
Re: CMS # 604640
Dear Mr. Nassif:
On January 31, 2020, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Nassif Wholesale LLC., located at 3330 2nd Avenue N, Suite 8, Palm Springs, FL 33461-3651. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the sesame seeds and tahini you import from your foreign supplier (b)(4); the tahini import from your foreign supplier (b)(4); and semolina you import from your foreign supplier (b)(4). Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of this FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.
Your significant violation of the FSVP regulation is as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:
• Sesame seeds and tahini imported from (b)(4).
• Tahini imported from (b)(4).
• Semolina imported from (b)(4).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
In addition, FDA has determined that your facility located at 3330 2nd Avenue N, Suite 8, Palm Springs, FL 33461-3651 is subject to the registration requirement in section 415 of the FD&C Act [21 U.S.C. § 350d] and our implementing regulations at 21 CFR Part 1, Subpart H. Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The failure of a food facility to renew its registration with FDA, as required by section 415(a)(3) of the FD&C Act, means that the facility has failed to register in accordance with section 415. Our records indicate that as of the date of this letter your registration was canceled. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act [21 U.S.C. § 331(dd)].
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of sesame seeds and tahini imported from (b)(4); tahini imported from (b)(4); and semolina imported from (b)(4). We may place the foods on detention without physical examination (DWPE) when you import the products.
You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Karen Y. Dodson, Compliance Officer, Division of Southeast Imports, 60 8th Street N.E., Atlanta, GA 30309. If you have any questions regarding this letter, you may contact Mrs. Dodson via email at karen.dodson@fda.hhs.gov. Please reference CMS # 604640 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ruth P. Dixon
Program Division Director
Division of Southeast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fatima-brothers-605562-04072020
WARNING LETTER
Fatima Brothers
MARCS-CMS 605562 — April 07, 2020
Mohammad S. Islam
President
Fatima Brothers
5601 56th Drive
Maspeth, NY 11378-1427
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 605562
April 7, 2020
Dear Mr. Islam:
On February 13, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Fatima Brothers Inc. located at 5601 56th Dr. Maspeth, NY 11378. We also conducted an initial inspection on July 25, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your (b)(4) Boiled Rice imported from (b)(4) imported from (b)(4) (Cake rusk) imported from (b)(4). Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on July 25, 2018, and the follow-up inspection on February 13, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:
• (b)(4) Boiled Rice imported from (b)(4)
• (b)(4) imported from (b)(4)
• (b)(4) (Cake rusk) imported from (b)(4)
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the (b)(4) Boiled Rice, (b)(4), and (b)(4) (Cake rusk) described above. We may place the foods you import on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 605562 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dawne Hines
Program Division Director
Division of Northeast Imports
WARNING LETTER
Prime Line Distributors, Inc.
MARCS-CMS 605669 — April 09, 2020
Recipient:
Mr. Dennis Landi
Vice President
Prime Line Distributors, Inc.
2800 SW 42nd Street
Ft. Lauderdale, FL 33312
United States
Issuing Office:
Division of Southeast Imports
United States
WARNING LETTER
April 9, 2020
Re: CMS # 605699
Dear Mr. Landi:
On February 12, 2020, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Prime Line Distributors Inc., located at 2800 SW 42nd St. Ft. Lauderdale FL 33312. We also conducted an inspection on August 28, 2017. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your FSVPs for food products you import including, but not limited to, hazelnut paste, Gran Padano cheese, and Parmigiano Reggiano cheese from your foreign suppliers. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial the FSVP inspection, and the follow-up inspection on February 12, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated February 26, 2020, where you included a one-page letter with an attachment. In your letter, you stated that you are working with a consulting company to develop your FSVP plan(s) in the next 60 days and that you obtained a letter of guarantee from (b)(4) for the hazelnut paste stating that they would comply with the FD&C Act. We are unable to evaluate the adequacy of your statement because you did not provide details as to what FSVP requirements your program will include or what products will be covered. You stated that you no longer import Gran Padano Cheese or Parmigiano Reggiano Cheese from (b)(4), and thus do not have an FSVP. Based on our review of your current shipping history, you imported Gran Padano on March 1, 2020, and Parmigiano Reggiano cheese on March 19, 2020, from other suppliers in Italy.
Your significant deviation is described below:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop FSVPs for each of the following foods:
• Hazelnut Paste imported from (b)(4)
• Gran Padano Cheese and Parmigiano Reggiano Cheese imported from (b)(4).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of Hazelnut Paste imported from (b)(4) and Gran Padano Cheese and Parmigiano Reggiano Cheese imported from (b)(4). We may place the food from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Carlos W. Hernandez, Compliance Officer, Division of Southeast Imports, 15100 NW 67th Ave. Suite 400, Miami, FL 33014. If you have any questions regarding this letter, you may contact Officer Hernandez via email at carlos.hernandez@fda.hhs.gov. Please reference CMS # 605699 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ruth P. Dixon
Program Division Director
Division of Southeast Imports
No comments:
Post a Comment